Published on October 5, 2020
New Therapy Reduces Recurrence in HR+, HER2- Early Breast Cancer
A combination drug therapy reduced the risk of recurrence by 25% for women and men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, the most common subtype of breast cancer.
The combination treatment also lowered the risk of developing metastatic breast cancer by 28%, with the highest reduction rates to the liver and bone.
Abemaciclib (Verzenio) Reduces Risk of Breast Cancer Recurrence in Study
Eli Lilly and Company announced last week that abemaciclib (Verzenio), in combination with adjuvant endocrine therapy demonstrated “a statistically significant improvement” in invasive disease-free survival (IDFS) in early high-risk breast cancer. High risk was defined as cancer that had spread to the lymph nodes, a large tumor size or a high tumor grade. IDFS includes the length of time before any cancer comes back, a new cancer develops or death.
“This is a major milestone for people living with high-risk HR+, HER2- early breast cancer — potentially one of the most notable treatment advances in the last two decades for this population of breast cancer patients,” said Dr. Stephen Johnston, professor of breast cancer medicine and consultant medical oncologist at The Royal Marsden NHS Foundation Trust and lead investigator for the monarchE trial. “…and if approved could represent a new standard of care for this population.”
Breast Cancer Clinical Trials
The monarchE phase III trial study included 5,637 patients with HR+ HER2- early breast cancer with clinical and/or pathological risk factors putting them at high risk for relapse. After completing their primary treatment, they were randomized to abemaciclib (150mg twice daily for two years) plus endocrine therapy or endocrine therapy alone. Patients were treated for two years and then continued with endocrine therapy alone.
At the time of analysis, approximately 70% of patients in each arm were still on the two-year treatment period, with a median follow-up of 15.5 months in both arms.
Breast cancer is the most common cancer among women worldwide, according to the World Health Organization. About 70% of breast cancers are HR+, HER2-; 30% of those diagnosed with the subtype are at risk of a recurrence, and possibly incurable metastatic disease. HR+, HER2- breast cancer is a complex disease, and many factors — such as if the cancer has spread to the lymph nodes and the biology of the tumor — can impact the risk of recurrence, Eli Lilly said.
Treating HR-Positive, HER2-Negative Breast Cancer
Verzenio is a CDK4/6 inhibitor, part of a class of drugs that target specific enzymes, called cyclin-dependent kinases 4 and 6. Blocking these enzymes interrupts signals that stimulate the growth of cancer cells. (Other CDK4/CDK6 inhibitors are palbociclib (Ibrance) and ribociclib (Kisqali). It is given in combination with an aromatase inhibitor, fulvestrant, or by itself for postmenopausal women with HR+, HER2- advanced or metastatic breast cancer.
The findings were presented at the Presidential Symposium at the European Society for Medical Oncology 2020 Virtual Congress on September 20 and published in the Journal of Clinical Oncology. Lilly plans to submit the data to regulatory authorities before the end of the year.
The results underscore the importance of biomarker testing for patients with breast cancer to determine treatment and see whether the tumor is responding.
Biomarkers and HER2 Status
Advances in identifying biomarkers have resulted in an increase in targeted therapies, said Dr. Natasha Hunter, an oncologist at Seattle Cancer Care Alliance, in an August 26 Patient Power webinar about metastatic breast cancer.
She noted the FDA’s approval last year of alpelisib (Piqray) for postmenopausal women and men with HR+/HER2- advanced breast cancer with a PIK3CA mutation. About 40% of patients with HR+/HER2- breast cancer have the mutation.
“I think that what's exciting to me is sort of a general sense that our ability to learn more about the disease and respond is really exponentially growing with our ability to process data and gather molecular information at a volume and a cost that's been unheard of in the past,” Dr. Hunter said. “And so, I think that it's a really exciting time. It's a bit of a Wild West, but I think it also is very, very exciting and hopeful.”
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- Verzenio® Significantly Reduced the Risk of Cancer Recurrence by 25% for People with HR+, HER2- High Risk Early Breast Cancer
- US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status
- Optimal management of hormone receptor positive metastatic breast cancer in 2016
- FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer
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